THE GAZETTE OF INDIA : JUNE 22, 1996/ ASADHA 1, 1918 [PART II-SEC 3(I)]

G.S.R. 254 – In exercise of the powers conferred by section 30 read with sections 14 and 17 of
the Atomic Energy Act, 1962 (33 of 1962) and in supersession of he Atomic Energy (Control of
Irradiation of Food) Rules, 1990 except as respects things done or omitted to be done before such
supersession, the Central Government hereby makes the following rules, namely:-

1. Short title and commencement:-

(1) These rules may be called the Atomic Energy (Control of Irradiation of Food)
Rules, 1996.
(2) They shall come into force on the date of their publication in the Official Gazette.

2. Definitions : In these rules unless the context otherwise requires:-

(a) “Act” means the Atomic Energy Act, 1962 (33 of 1962),

(b) “Applicant” means the person making an application for the grant of licence;

(c) “Certificate of approval” means the certificate of approval granted by the

competent authority for operating an irradiation facility in accordance with rule 5;

(d) “Certificate of irradiation” means the certificate of irradiation issued by the

licensee under rule 12;

(e) “Certificate of release” means certificate of release issued by the licensing

authority under rule 25;

(f) “Competent authority” means such officer or authority directed by the Central
Government under Section 27 of the Act to exercise the powers or discharge the
duties under these rules;

(g) “Dosimetry” means the method to measure the absorbed dose of radiation by the
food;

(h) “Food” means article of food referred to in column 2 of Schedule I;

(i) “Form” means the Form annexed to these rules;

(j) “Inspection Report” means the inspection report referred to in rule 10;

(k) “Irradiation facility” means any facility which is capable of being utilised for the
treatment of food by radiation;

(l) “Irradiated food” means articles of food subjected to radiation by:-

(i) Gamma rays;

 (ii) X-rays generated from machine sources operated at or below an energy
level of 5 million electron volts;

(iii) Sub-atomic particles, namely electrons generated from machine sources

operated at or below an energy level of 10 million electron volts, to dose
levels as specified in Schedule I.

(m) “Licence” means licence for operating an irradiation facility issued under rule 4;

(n) “licensee” means the person named in the licence in whose favour the licence is
issued;

(o) “Licensing authority” means the Central Government or such officer or authority
directed by the Central Government under section 27 of the Act to grant license
under section 14 of the Act;

(p) "Operational Limits” means limits specified by the competent authority on the
level of radiation to workers and members of the public and on the level of
radioactive contamination from the radioactive sources used in the irradiation
facility;

(q) “Operator” means any person, appointed as such by the licensee and who shall
have the qualification and other requirements as specified in paragraph 2 of
Schedule II;

(r) “Quality Control Officer” means any person appointed as such by the licensed
who shall have the qualification and other requirements as specified in paragraph
3 of Schedule II;

(s) “Radiological Safety Officer” means any person appointed as such by the licensee
who have the qualification and other requirements as specified in paragraph 1 of
Schedule II;

(t) “Schedule” means “Schedule annexed to these rules”

3. Conditions precedent for the issue of a licence:- No licence for operating an irradiation
facility shall be granted, unless the applicant obtains a certificate of approval from the
competent authority, after submitting documents as specified in Schedule III to the effect
that the facility is in conformity with the general conditions for design, operation and
efficiency criteria as specified in Schedule IV.

4. Licence:-
 (1) An application for a licence shall be made to the licensing authority in Form I and
shall be accompanied by:-

(a) a certificate of approval;

(b) fee of rupees five hundred payable in the form of a bank draft drawn in
favour of the licensing authority;

(2) If the licensing authority is satisfied that the applicant is capable of operating an
irradiation facility in accordance with these rules, it shall issue a licence in Form
IV.

(3) If the licensing authority is satisfied that the applicant is not capable of operating
an irradiation facility in accordance with these rules, it may, after giving the
applicant reasonable opportunity of being heard against the proposed refusal of
licence, by order setting out the reasons therein, refuse to grant the licence.

(4) Every order refusing to grant the licence sub-rule (3) shall be communicated to
the applicant, by sending a copy of the order by registered post to the address
given in the application.

5. Certificate of approval:-

(1) An application for a certificate of approval shall be made to the competent

authority in Form III.

(2) If the competent authority is satisfied that the applicant satisfies the requirements
as specified in Schedule III and IV, it shall grant a certificate of approval in Form
II.

(3) If the competent authority is satisfied that the applicant does not satisfy the
requirements as specified in Schedule III and IV, it may, after giving the applicant
a reasonable opportunity of being heard against the proposed refusal of the
certificate of approval, by order, setting out the reasons therein, refuse to grant the
certificate of approval.

(4) Every order refusing to grant the certificate of approval under sub-rule (3), shall
be communicated to the applicant by sending a copy of the order by registered
post to the address given in the application.

6. Power to suspend the certificate of approval :

(1) If the competent authority is satisfied, on the basis of the inspection report, that
any irradiation facility has ceased to conform to the safety and efficiency criteria
as specified in Schedule IV; it may for reasons to be recorded in writing, make
 and order suspending the certificate of approval and call upon the licensee to
rectify the defects mentioned therein within a period of thirty days from the date
of receipt of the order.

(2) The order of the competent authority made under sub-rule (1) along with the copy
of the inspection report shall be communicated to the licensee who shall on
receipt of the same, cease to operate the irradiation facility until the suspension of
the certificate of approval is revoked under sub-rule (5).

(3) The competent authority shall transmit copies of the order and inspection report
referred to in sub-rule (2) to the licensing authority.

(4) The competent authority shall enter in the certificate of approval the particulars of
inspection.

(5) Where the competent authority is satisfied that pursuant to the order made under
sub-rule (1) the licensee has rectified the defects mentioned therein, it may revoke
the suspension of the certificate of approval and communicate in writing the
decision to the licensee.

(6) If the defects mentioned in the order are not rectified by the licensee within the
period mentioned therein, the competent authority shall report the matter to the
licensing authority for necessary action.

(7) Any person aggrieved by the order of suspension of certificate of approval by the
competent authority may within a period of fifteen days from the receipt of the
communication of such suspension prefer an appeal to the Atomic Energy
Commission.

7. Power to suspend the Licence:-

(1) If the licensing authority is satisfied, on the basis of the inspection report that the
licensee has failed to ensure that the irradiation facility under his control conforms
to the safety and efficiency criteria specified in Schedule IV, it may for reasons to
be recorded in writing make an order suspending the licence and call upon the
licensee to rectify the defects mentioned therein within a period of thirty days
from the date of receipt of the order.

(2) The period of thirty days stipulated under sub-rule (1) of rules 6 and 7 may be
condoned by the licensing authority after having satisfied himself with the fact
that the licensee is not able to rectify the defects for reasons beyond his control
within the stipulated period of thirty days.

(3) The order made by the licensing authority under sub-rule (1) along with the copy
of the inspection report shall be communicated to the licensee, who shall on
 receipt of the same, cease to operate the irradiation facility until the suspension of
the licence is revoked.

(4) Where the licensing authority is satisfied that pursuant to the order made under
sub-rule (1), the licensee has rectified the defects mentioned therein, it may
revoke the suspension of the licence and communicate the decision to the
licensee.

(5) Any person aggrieved by the order of suspension or revocation of a licence by the
licensing authority may within a period of fifteen days from the receipt of the
communication of such suspension or revocation prefer an appeal to the Central
Government.

8. Revocation of licence:- Notwithstanding anything contained in rule 4, the licensing

authority may after giving the licensee a reasonable opportunity of being heard, by order
setting out the reasons therein in writing, revoke any licence or modify the terms and
conditions of any licence on any of the following grounds, namely:-

(1) Where the certificate of approval has been suspended and the competent authority
has reported that the licensee has not rectified the defects mentioned in the order
of suspension within the period stipulated therein; or

(2) Where the licence has been suspended and the licensee has not rectified the
defects mentioned in the order of suspension within the period stipulated therein;
or

(3) Where in the opinion of the licensing authority, it is necessary to do so, in order to
ensure safety of persons whosoever may suffer any injury because of any
negligence in the process of irradiation.

9. Conditions for irradiation of food:-

(1) The licensee shall not undertake irradiation of any food unless in his opinion such
irradiation is necessary for its preservation, protection against parasites or
improvement of its hygienic or technological quality.

(2) The licensee shall ensure that:-

(a) the Quality Control Officer has satisfied himself that the food to be
irradiated is of good quality.

(b) in the case of packaged products, the packing material conforms to the
standards specified in Schedule VII.

(c) the irradiated food is readily identified so as to prevent it from being

subjected to subsequent irradiation
 (d) the dose limit, radiation source and irradiation conforms to the conditions
specified in Schedules I and V.

(e) the irradiation facility is operated only by the operator

10. Period Inspection of facilities:-

(1) The competent authority or any person authorised by him in this behalf shall
undertake inspection of the irradiation facility at least twice in a year, but the
maximum gap between two inspections shall not exceed 8 months.

(2) The particulars of the inspection shall be recorded by an entry on the certificate of
approval

(3) A copy each of the inspection report shall be forwarded to the licensee and to the
licensing authority

11. Record of food irradiation:-

(1) The licensee shall maintain, for each source of radiation used, a record in Form V
indicating, for each batch of food subjected to radiation treatment:-

(a) the serial number of the batch;

(b) the date of irradiation;

(c) the nature and the quality of irradiated food and the batch number;

(d) the type of packaging used during the radiation treatment in the case of
packaged products;

(e) the control and measurement performed during the treatment, particularly
as regards the minimum and maximum limits of radiation dose;

(f) where appropriate, all supplementary information required by the specific

irradiation conditions provided for in Schedule V;

(g) any incidents and anomalies observed during the irradiation treatment.

(2) The record shall contain the names and address of the operators and the quality
control officer and the identification number of the irradiation facility.

(3) The licensee shall retain the records for a period of five years.
 (4) The licensee shall maintain the record of standard model for the food irradiation
in respect of each batch of food as specified in Form V.

12. Certificate of irradiation:-

(1) The licensee shall, on the basis of the data entered in the record of irradiated food,
issue a certificate of irradiation for every batch of food item which has undergone
irradiation in his facility.

(2) A copy of the certificate of irradiation shall be maintained by the licensee.

13. Irradiation voucher:- The licensee shall issue to the person from whom an order for
the irradiation of food has been received, an irradiation voucher for each batch of food
containing the following particulars, namely:-

(1) the identification number of the irradiation facility together with the names and
addresses of the operator and quality control officer;

(2) the nature and quality of the batch of irradiated food and also the purpose of the
irradiation;

(3) the date of the radiation treatment;

(4) the radiation source used and specific dose of radiation;

(5) the serial number of the batch which has been subjected to the treatment which
number must correspond to the information in the irradiation record;

(6) date and signature of the licensee.

14. Maintenance of log books:- Every licensee shall maintain and make available to any
person duly authorised by the competent authority for inspection, a log book containing
the following particulars, namely:-

(1) description of the facility;

(2) source details;

(3) the name of supplier of the source and his address;

(4) the identity of Radiological Safety Officer (RSO).

15. Control of irradiation facility:-

 (1) The competent authority or any person authorised by him in his behalf shall
undertake verification to ensure that the operation of the facility and the use of
radiation treatment procedures conform to the general and specific conditions as
specified in Schedule IV.

(2) The licensee shall provide all reasonable facilities to the competent authority or
any person authorised by him, to carry out inspection and measurement
procedures as may be necessary.

16. Powers and duties of person authorised to inspect:- (1) The competent authority or any
person authorised by him in this behalf shall-

(a) have the right of access:-

(i) to any place which is used for irradiation of food or for storage of food
which has been or has to be irradiated;

(ii) to all documents relating to the irradiation facility, the batches of food
which have been or are to be irradiated, a certificate of approval, the
copies of the inspection report, order of suspension, modification or
revocation of licence, food irradiation records and the documents relating
to purchase and sale accompanying the batches of food.

(b) to check the performance of the irradiation unit and measure the dosage to which
the food is subject to.

17. Radiological Safety Officer:- The qualifications of Radiological Safety Officer are given
in Schedule II. No person shall be appointed as a Radiological Safety Officer unless such
person:-

(1) possesses a certificate towards his qualification by an institution or authority

approved by the competent authority.

(2) is familiar with the operating and emergency procedures of the irradiation unit
and has demonstrated his understanding thereof to the satisfaction of the
competent authority.

(3) is familiar with the rules, notification and orders applicable to the irradiation
facility and has demonstrated his understanding thereof to the satisfaction of the
competent authority.

(4) has demonstrated to the satisfaction of the Competent authority competence to use
the irradiation facility and the radiation instruments to be used in his assignment..

18. Duties of Radiological Safety Officer: The Radiological Safety Officer shall –
 (1) instruct the radiation workers under his charge on the hazards of radiation and on
suitable safety measures and work practices aimed at minimising exposure to
radiation;

(2) take all necessary steps aimed at ensuring that the operational limits as specified
in Schedule VIII are not exceeded;

(3) carry out leakage tests as specified by the competent authority in Schedule IX and
tests of safety related systems;

(4) investigate and initiate prompt and suitable remedial measures in respect of any
situation that could result in radiation hazard;

(5) ensure that reports on all hazardous situation along with details of any immediate
remedial measures that may have been initiated, are made available immediately
to his employer;

(6) assist the licensee in the safe disposal of decayed radioactive sources in the
manners approved by the competent authority.

19. Monitoring of personnel:- The licensee shall ensure that:-

(1) every person entering the irradiation facility wears separate personnel monitoring
device provided by him.

(2) such personnel monitoring devices are processed by an agency approved by the
competent authority.

(3) investigation reports regarding all excessive exposures are forwarded to the
competent authority.

(4) the workers exposed to radiation have been medically examined as specified by
the competent authority.

20. Operating procedures:- The licensee shall prepare a detailed operating procedure based
on the manufacturer’s manual which shall inter alia provide that:-

(1) the irradiation facility shall be operated only in such a way that no person is likely
to be exposed to radiation doses in excess of the operational limits notified by the
competent authority.

(2) it shall be impossible to resume operation of irradiation facility after the return of
the source to the fully shielded position without complying with the requirements
such as interlocked controls for personnel access, radiation room lock-up
sequence and source exposing operations.
 (3) a single multipurpose key which is to operate the control console, to gain access
to the radiation room and to activate safety related interlocks is available.

(4) The procedures and occasions for conducting radiation surveys and contamination
tests, are devised.

(5) The procedures for locking and the use of facility are available.

(6) Monitoring of the personnel and the use of area monitoring equipment is made
mandatory.

(7) Transportation of sealed sources used in irradiation unit is undertaken in a safe

manner.

(8) Records are maintained in proper form.

(9) For inspection and maintenance procedures, approved by the competent authority,
are devised for the radiation facility.

(10) In the event of an accident persons to be notified in accordance with the procedure
specified by the competent authority.

(11) The radiation zone monitor is so integrated with the personnel access door
interlocks to prevent room access of specified values or if the detector
malfunctions or is turned off.

(12) The monitor shall also generate audible and visible alarm signals if the radiation
level exceeds that when source is in the fully shielded position.

21. Emergency procedures:-

(1) The licensee shall prepare detailed emergency procedures for each type of
emergency that may reasonably be anticipated.

(2) The procedure should be brief and should be expressed in the form of instructions
which can be understood by non-technical persons.

(3) The procedures should describe situations requiring emergency action and specify
immediate action to be taken to minimise radiation dose to persons in the vicinity
of the irradiation facility.

22. Security of irradiation facility:- The licensee shall ensure that during the operation of the
irradiation facility, direct surveillance of the facility is maintained in order to prevent
unauthorized entry licensee shall conspicuously display the radiation onto the facility.
23. Posting of radiation warning signs:- The warning sign as given below at the site in which
irradiation is in progress

BASIC TREFOIL SYMBOL WITH PROPORTIONS BASED ON A CENTRAL CIRCLE OF RADIUS X. THE
MINIMUM ALLOWABLE SIZE OF X SHALL BE 4 mm.

24. Radiation survey instruments:- The licensee shall not commence operation of any
irradiation facility under his control unless the irradiation facility is equipped with
instruments as specified by the competent authority in Schedule VI.

25. Decommissioning:-

(1) No licensee, shall decommission any irradiation facility under his control unless
he:-
(a) obtains the previous permission of the licensing authority

(b) undertakes to decommission the irradiation facility in the manner specified

by the competent authority

(c) undertakes to bear all the expenses of such decommissioning

(2) The licensee shall not use the site used for the irradiation facility for any other
purpose, unless he obtains the certificate of release from the licensing authority.
 (3) The licensing authority may on the application of the licensee and after obtaining
a report from the competent authority, in its discretion issue a certificate of
release.

26. Disposal of decayed sources: - The licensee shall at his expense, ensure the safe disposal
of the radioactive sources in such manner as may be approved by the competent
authority.

SCHEDULE I
[See rules 2 (h) and 9(2)(d)]
Technological conditions for irradiation

Dose (kGy)
Sl. Name of food Purpose of irradiation Minimum Maximum Overall Specific conditions
No. average
(1) (2) (3) (4) (5) (6) (7)
1. Onions To inhibit sprouting 0.03 0.09 0.06
(30 Gy) (90 Gy) (60 Gy)
2. Potatoes To inhibit sprouting 0.06 0.15 0.10
(60 Gy) (150 Gy) (100 Gy)
3. Frozen sea- To reduce the number 4 6 5 Irradiation should
foods of certain pathogenic be carried out in a
microorganisms such frozen state
as Salmonella in
packaged frozen sea-
foods.
4. Spices To control insect 6 14 10 Irradiation under
infestation to reduce prepacked
microbial local and condition
pathogenic
microorganisms

SCHEDULE II
[see rule 2(q), (r) and (s)]

Qualifications of Personnel

1. Radiological Safety Officer: The minimum qualification: He should be a Science

graduate with physics as one of the subjects.

He should have also successfully undergone instructions specified for the training of
Radiological Safety Officer. He should have also successfully undergone instructions
specified for the training of Radiological Safety Officer level III as prescribed by Atomic
Energy Regulatory Board and should posses a valid certificate to that effect. The subject
 for instructions include fundamentals of radiation and radiation protection, concept of
dose limit, use of instruments and survey techniques in radiation detection; and
knowledge of personnel monitoring equipment, inspection and maintenance of safety
interlocks, and operation and emergency procedures.

2. Operator:- The operator should be Science graduate/ Diploma holder either in Electrical
or Mechanical Engineering.

The subject for inclusion in the instruction of the operator will be the same as those
prescribed for Radiological Safety Officer except that he shall be given training in
elements of food technology and food irradiation technology also.

Food Irradiation Technology:-

(a) Details of radiation sources used for food irradiation.

(b) Measurement of absorbed doses during irradiation using proper dosimeter for
various types of sources and maintenance of the record of dosimetry and source
activity.

(c) Source-product geometry to increase efficiency of radiation utilization.

(d) Operation of radionuclide irradiator to ensure correct operational and of correct

safe position operational and of correct safe position of the source which should
be interlocked with the product movement.

(e) Maintenance of irradiator.

(f) Irradiation technology of individual food items.

3. Quality Control Officer:- The qualification of the Quality Control Officer should be
either M.Sc./B. Tech in Microbiology, Food Technology or Food Chemistry

(1) The Quality Control Officer shall ascertain the quality of the food.

SCHEDULE III
(see rule 3)

Document to be submitted to the competent authority for obtaining approval of irradiation

facilities.

The applicant shall submit to the competent authority:-

(1) The complete design drawings of the facility indicating the details of the shielding
surrounding the source, wall thickness, labyrinth access, openings voids, reinforcements,
mechanical and electrical safety system, ventilation, fire protection systems.

(2) The environs of the facility including residential complexes, occupancy within 50m
radius of the facility, geology of the location, water table, soil characteristics, seismicity.

(3) Complete description of the radiation source, address of the supplier and the operating
condition of the source such as source drive system.

(4) Safety analysis report to demonstrate the adequacy of radiation safety under normal and
anticipated accident conditions.

SCHEDULE IV
(See rules 3 and 6)

A. Condition for the operation of irradiation facilities.

1. Introduction:-

1.1 Only irradiation facilities based on the use of either a radionuclide source
(60Co or 137Cs) or X-rays and electrons generated from machine sources should
be used.

1.2 The Irradiation facility, may be of two designs either “continuous” or “batch”
type.

1.3 The irradiation facility shall make use of accepted methods for measuring the
absorbed radiation dose and of the monitoring of the physical parameters of the
process.

2. Irradiation plants:-

2.1 The manufacturers of the facility should state the activity of the source in
Becqueral (Bq) in the case of radionuclide source, and it should be recorded. The
recorded activity should take into account the natural decay rate of the source and
should be accompanied by a record of the date of measurement of recalculation.

2.2 The irradiation facility using radionuclide sources shall have a well separated and
shielded depository for the source element and a treatment areas which can be
entered only when the source is in the safe position.
 2.3 There should be a positive indication of the correct operational and of the correct
safe position of the same which should be interlocked with the product movement
system.

2.4 In the case of machine sources the average beam power should be adequately
recorded.

2.5 There should be a positive indication of the correct setting of all machine
parameters which should be interlocked with the product movement system.

2.6 A beam scanner or a scattering device (e.g. the converting target) must be
incorporated in a machine source to obtain an even distribution of the radiation
over the surface of the product.

2.7 The product movement, with width and speed of the scan and the beam pulse
frequency (if applicable) should be adjusted to ensure a uniform surface dose.

3. Dosimetry and Process Control:-

(1) Certain dosimetry measurements (para.B) should be made prior to the irradiation
of any food stuff.

(2) The dosimetry measurement should be done for each new food irradiated,
irradiation process, and whenever modifications are made to source strength or
type and to the source product geometry.

(3) Routine dosimetry should be made during operation and records of such
measurements must be available for inspection.

(4) The measurements of facility parameters governing the process such as

transportation speed, dwell time, source exposure time, machine beam
parameters, should be made regularly during the operation and record must be
kept for inspection.

4. Good radiation processing practices:-

(1) The design of the irradiator should have he facility to optimize the dose
uniformity ratio to ensure appropriate dose rates and where necessary to permit
temperature control during irradiation (e.g. for treatment of frozen food) and also
control of atmosphere.

(2) Care must be exercised to minimize mechanical damage to the product during
transport, irradiation and storage and to use irradiator to its maximum efficiency.

(3) Where the food to be irradiated is subjected to special standards for hygiene or
temperature, control, the facility must permit compliance with these standards.
5. Product and Inventory Control:-

(1) The incoming product should be physically separated from the outgoing irradiated
product.

(2) Where appropriate a visual colour change radiation indicator should be affixed to
each product pack for ready identification of irradiated and non-irradiated
products.

(3) Records should be kept in the facility record book which show the nature and kind
of the product being treated, its identifying marks if packed or, if not, the shipping
details, its bulk density, the type or source or electron machine, the dosimetry, the
dosimeters used and details of their calibration, and the dates of the treatment.

(4) All products shall be handled, before and after irradiation, according to accepted
good manufacturing practices taking into account of the particular requirements of
the technology or the process (Schedule I). Suitable facilities for refrigerated
storage may be required.

B. DOSIMETRY

1. The overall average absorbed dose: It can be assumed for the purpose of the
determination of the wholesomeness of food treated with an overall average dose
of 10 kGy or less, that all radiation chemical effects in that particular dose range
are proportional to dose.

The overall average dose, D, is defined by the following integral over the total
volume of the goods
Γ(x, y, z ), d (x, y, z ).dv
1
M∫
D=

Where
M = the total mass of the treated sample
Γ= the local density at the point (x,y,z)
d = the local absorbed dose at the point (x,y,z)
dv = dx dy dz the infinitesimal volume element which in real case is represented
by the volume fractions.

The overall average absorbed dose can be determined directly by homogenous products
or for bulk goods of homogeneous bulk density by distributing an adequate number of dose
meters strategically and at random throughout the volume of the goods. From the dose
distribution determined in this manner an average can be calculated which is the overall average
absorbed dose.
 If the shape of the dose distribution curve through the product is well determined the
positions of minimum and maximum dose are known. Measurements of the distribution of dose
in these two positions in a series of samples of the product can be used to give an estimate of the
overall average dose.

In some cases the mean value of the average values of the minimum (Dmin) and
maximum (Dmax) dose will be a good estimate of the overall average dose, i.e. in these cases

Over average dose = (Dmax + Dmin)/ 2

2. Effective and limiting dose values

(1) Some effective treatment e.g. the elimination of harmful microorganisms or a

particular shell-life extension or a disinfestation requires a minimum absorbed
dose. For other applications too high an absorbed dose may cause undesirable
effects or an impairment of the quality of the product.

(2) The design of the facility and the operational parameters have to take into account
minimum and maximum dose values required by the process. In some low dose
applications it will be possible within the terms of paragraph 4 on Good Radiation
Processing Practice to allow a ratio of maximum to minimum dose of greater than
3.

(3) With regards to the maximum dose value under acceptable wholesomeness
considerations and because of the statistical distribution of the dose of mass
fraction of product of at least 97.5% should receive an absorbed dose of less than
15 kGy when the overall average dose is 10 kGy.

3. Routine dosimetry

Measurements of the dose in a reference position can be made occasionally throughout

the process. The association between the dose in the reference position and the overall
average dose must be known. These measurements should be used to ensure the correct
operation of the process. A recognized and calibrated system of dosimetry should be
used.

A complete record of all dosimetry measurements including calibration must be kept.

4. Process Control

(1) In the case of a continuous irradiation facility employing radionuclide, it will be

possible to make automatically a record of transportation speed or dwell time
together with indications of source and product positioning. These measurements
can be used to provide a continuous control of the process in support of routine
dosimetry measurements.
(2) In a batch operated radionuclide facility automatic recording of source exposure
time can be made and a record of product movement and placement can be kept to
provide a control of the process in support of routine dosimetry measurements.

(3) In a machine facility a continuous record of beam parameters, e.g. voltage,

current, scan speed, scan width, pulse repetition and a record of transportation
speed through the beam can be used to provide a continuous control of the process
in support of routine dosimetry measurements.

SCHEDULE V
[See rule 9(2)(d)]

General conditions for Irradiated Foods

1. SCOPE

These conditions applies to foods processed by irradiation. It does not apply to

foods exposed to doses imparted by measuring instruments used for inspection
purposes.

2. GENERAL CONDITIONS FOR THE PROCESS

(1) Radiation Source :

The following types of ionizing radiation may be used:-

(a) Gamma rays from the radionuclides 60Co or 137Cs;

(b) X-rays generated from machine sources operated at or below an

energy level of 5 MeV;

(c) Electrons generated from machine sources operated at or below an

energy level of 10 MeV.

(2) Absorbed Dose:

The overall average dose absorbed by a food subjected to radiation

processing should not exceed 10 kGy.

(3) Facility and Control of the Process

2.3.1 Radiation treatment of foods shall be carried out in facilities licenced and
registered for this purpose by the licensing authority.
2.3.2 The facilities shall be designed to meet the requirements of safety, efficacy
and good hygienic practices of food processing.
 2.3.3 The facilities shall be staffed by adequately trained and competent
personnel.
2.3.4 Control of the process within the facility shall include the keeping of
adequate records including quantitative dosimetry.
2.3.5 Premises and records shall be open to inspection by appropriate national
authorities.

3. TECHNOLOGICAL REQUIREMENTS:

(1) Conditions for Irradiation:

The irradiation of food is justified only when it fulfills a technological need.

(2) Food Quality and Packaging Requirements :

The doses applied shall be commensurate with technological and public health
purposes to be achieved and shall be in accordance with good radiation processing
practice. Foods to be irradiated and their packaging materials shall be of suitable
quality, acceptable hygienic conditions and appropriate for this purpose and shall
be handled, before and after irradiation, according to good manufacturing
practices taking into account the particular requirements of the technology of the
process.

4. LABELLING

(1) Inventory control:

For irradiated foods, whether prepacked or not, the relevant shipping documents
shall give appropriate information to identify he registered facility which has
irradiated the food, the date(s) of treatment and lot identification.

(2) Prepacked foods intended for direct consumption:

The labelling of prepackaged irradiated foods shall be in accordance with the

relevant provisions given in Prevention of Food Adulteration Rules.

(3) Food in bulk containers:

The declaration of the fact of irradiation shall be made clear on the relevant
shipping documents.

5. RE-IRRADIATION
 (1) Except for foods with low moisture content (cereals, pulses, dehydrated foods and
other such commodities) irradiated for the purposes of controlling insect
reinfestation, foods irradiated in accordance with 2 and 3 of this standard shall not
be re-irradiated.

(2) For the purpose of this standard food is not considered as having re-irradiated
when

(a) the food prepared from materials which have been irradiated at low levels
e.g. about 1 kGy, is irradiated for another technological purpose;

(b) the food containing less than 5% of irradiated ingredient, is irradiated, or

when

(c) the full dose of ionizing radiation required to achieve the desired effect is
applied to the food is more than one instalment as part of processing for a
specific technological purpose.

(3) The cumulative overall average dose absorbed should not exceed 10 kGy as a
result of re-irradiation.

SCHEDULE VI
[See Rule 24]

Radiation Survey Instruments required for radiation monitoring.

Either

A. 1. Radiation Survey Meter (G.M. Type 0.2 mR/hr or with other appropriate
measurement range)
and
2. Radiation Survey Meter (Ionization chamber type 0-5R/hr. or with other
appropriate measurement range)
or
B. 1. Wide range Survey Meter (G.M. Type 0-100R/hr. or with other
appropriate measurement range)
 2. Alternatively, any single or combination of radiation survey meters
recognised by the competent authority as equivalent to the above.

SCHEDULE VII
[See Rule 9(1)(b)]

Standards of packaging material:

1. (1) Where packing is essential to prevent post-treatment recontamination, the

food should be packed before treatment.

(2) Package size especially with bulk packs should be such that they can be
handled efficiently thereby avoiding excessive delays and temperature
abuse.

(3) The choice of the packing material and the nature of the container for
specific food is usually determined by the purpose they are to serve and
storage conditions, such as prevention of moisture loss or moisture uptake,
to provide an atmosphere devoid of air, or to avoid mechanical damage to
food.

(4) Sterilized food must have containers which prevent access to bacteria or
other micro-organisms.

2. Rigid Containers:

(1) Primary rigid container used for irradiated food is metal can, Steel containers, tin-
plated and lined with appropriate enamel such as polybutadiene or epoxy-phenolic
have been found to be satisfactory.

(2) Secondary rigid containers made of wood, fibre board or glass are also used.

3. Flexible packaging material:- Flexible plastic containers because of their low density are
highly suitable for packing irradiated food. Films over 76 cm thick are satisfactory for
preservation of irradiated products. In case laminates are used their performance should
satisfy the following criteria:-

(i) The films are not changed adversely:-

(a) in their protective characteristics (e.g. seal stability, permeability, etc),

 (b) by radiation induced changes in the food,

(c) causing transmission of toxic or potentially toxic, and substances to the

food.

(ii) Polymeric films recommended for use upto 10 kGy are:-

(a) Nitrocellulose or vinylidene coated cellophane;

(b) Wax coated paper board;

(c) Glassine paper;

(d) Polystyrene;

(e) Rubber hydrochloride;

(f) Vinylidiene chloride – vinyl chloride;

(g) Polyethylene;

(h) Polyethylene terephthalate;

(i) Nylon 6;

(j) Nylon 11;

(k) Vinyl chloride – vinyl acetate

(l) Vegetable parchment

SCHEDULE VIII
[See Rule 18(2)]

Operational Limits:

Effective Dose Limits:-

1. The cumulative effective dose constraint for five years from January 1, 1994 to
December 31, 1998 will be one hundred milli Sievert (100 mSv) for individual radiation
workers.

2. The annual effective dose to individual workers in any calender year during the five-year
block shall not exceed the limit of thirty milli Sievert (30 mSv).
 SCHEDULE IX
[See Rule 18(3)]

Leakage and safety related tests.

1. Wet storage irradiators:

(1) The resin bed in the water conditioning system shall be daily checked with a
radiation survey instrument. The survey instrument should be sensitive enough to
detect minimum radioactive of 2000 Eq. in the resin bed. In the event of
detection of activity above this level, water circulation system shall be stopped
and irradiator shall be withdrawn from service.

(2) In addition the pool water shall be checked for contamination by using an on-line
radiation monitor on a pool water circulating system.

(3) The detection of above normal radiation levels must activate an alarm. Activation
of alarm must automatically cause the water purification system to shut off.

2. Dry storage irradiators :

Swipe test using a moist paper of 100 square centimeter area shall be conducted weekly
on the closest accessible surface near the source in storage condition. Activity on the
sample shall be counted by a radiation survey instrument with a minimum detection
capability of 2000 Bq on swipe sample. In the event of detection of activity above this
level, irradiator shall be withdrawn from service.
 Form I
[See rule 4(1)]

APPLICATION FOR OBTAINING A LICENCE FOR AN IRRADIATION FACILITY

1. Name of the applicant

2. Address of the applicant
3. Installation for which approval is applied for
4. Name and designation of the Head of Installation
5. Names, qualifications and experience of Personnel
Category of Name Academic Qualification Type of training When and Duration of
Personnel experience where trained training
Operator
Radiological
Safety Officer
Quality Control
Officer

6. Proposed date of starting the Irradiation Facility:

7. Details about the Irradiation Facility:

(1) Identification number of the facility

(2) Location and address
(3) Source details

Name of radionuclide Activity

Radiation generating plant Energy output
X-ray unit
Electron Accelerator

(4) Name of the supplier and his address

(5) Purpose for which the irradiation facility will be used

8. Please attach the following additional information to the application:

(1) A site plan (1:500 scale or as appropriate) of the installation indicating the
location of building including residential complexes.
(2) Architectural blue prints (appropriate scale) showing layout of equipment.
(3) Complete design drawing of the facility including details of
(4) Description of the organisational structure including delegation of authority
and responsibility for operations at the facility.

9. Please indicate as appropriate:

(1) the irradiation facility is yet to be built

(2) the irradiation facility is already built and equipped
(3) Existing irradiation facility is to be modified as per details enclosed.
10. I hereby certify that:

(1) all the statements made above are correct to the best of my knowledge and belief.
(2) no operations will be carried out for purposes other than those specified under
item 7 (5) of this form.
(3) all provisions of the Atomic Energy (Control of Irradiation of Food) Rules, 1996
shall be strictly complied with.
(4) the irradiation facility shall not be transferred/sold/rented by me/ us to another
without the prior permission of the competent authority.
(5) no radiation sources for the irradiation unit will be transported without the prior
permission of the competent authority.
(6) full facilities will be accorded by me/us to any authorised representatives of the
competent authority or licensing authority to inspect the installation at any time.
(7) radiation surveillance and medical surveillance of all persons engaged in radiaiton
work as required by the competent authority will be duly carried out at my/our
expense.
(8) all recommendations that may be made from time to time by the competent
authority in respect of radiation safety measures will be duly implemented.
(9) duly qualified/experienced radiological safety officers will be appointed before
the commencement of the operation of the facility.
(10) any change in the personnel listed in this application will be intimated forthwith
to the licensing authority and the competent authority.
(11) the rules regarding decommissioning, disposal of decayed sources and rules of
the site of the decommissioned facility shall be strictly complied with.

Date: Signature of the Applicant Institution and Seal

FORM II
[See rule 5 (2)]

CERTIFICATE OF APPROVAL FOR IRRADIATION FACILITY

Mr./Messers .... ...........................................................................................................

Of ...............................................................................................................................
having complied with the conditions prescribed in the Atomic Energy (Control of
Irradiation of Food) Rules, 1996 for the approval of the irradiation facility is/are
hereby granted the certificate of approval for his/their irradiation facility.

The description of the irradiation facility and other details are shown as under:

1. Identification Number
2. Name and Addresses
(i) Licensee
(ii) Radiological Safety Officer
(iii) Quality Control Officer
 (iv) Operator
3. Kind and nature of the food product to be irradiated
4. Radiation source used
(i) Type of source
(ii) Total activity content in the case of radionuclide sources
(iii) Type of operation
Batch
Continuous
(iv) Source product geometry
(v) Dose rate
5. Specific operation conditions

COMPETENT AUTHORITY
(Seal of Office)
 FORM III

[See rule 5 (1)]

APPLICATION FOR OBTAINING THE CERTIFICATE OF APPROVAL FOR AN IRRADIATION

FACILITY

1. Name of the applicant

2. Address of the applicant
3. Installation for which approval is applied for
4. Names, qualifications and experience of Personnel

-----------------------------------------------------------------------------
---------
Category Name Academic Type of training When and
Duration of
Of Personnel Qualification experience where trained
training

-----------------------------------------------------------------------------
----------
Operator
Radiological
Safety Officer
Quality Control
Officer
-----------------------------------------------------------------------------

5. Proposed date of starting the irradiation facility

6. Are the personnel provided with facilities for:

(a) Personnel dose monitoring
(b) Medical Surveillance

7. Details about the Irradiation Facility:

(1) Identification number of the facility
(2) location and its address
(3) Source detail
Name of radionuclides
Radiation generating plant Activity
------------------------
Energy Output
X-ray unit
Electron Accelerator

(4) Name of the supplier and his address

(5) Purpose for which the irradiation facility will be used.

8. Please furnish the following:

(1) A site plan(l:500 scale or as appropriate) of the installation

indicating the location of buildings including residential complexes.
Occupancy within 50 meters radius of the facility.
(2) Architectural blue prints (appropriate scale) showing layout of
equipment.
 (3) Details on geology of the location, water table, soil characteristics,
seismicity.
(4) Complete design drawing of the facility including details of shielding
surrounding of source, wall thickness and labyrinth access if
applicable; openings, voids, reinforcements, mechanical and electrical
safety systems, ventilation. Fire protection systems.
(5) Source movement system (where appropriate).
(6) Safety analysis report to demonstrate the adequacy of radiation safety
under normal and anticipated accident condition as detailed in ruies 20
and 21.
(7) Operating and emergency procedures.
(8) List of calibrated radiation monitoring equipment in working
condition.
(9) Description of the organisational structure including delegation of
authority and responsibility for operation of the facility.

9. Any other information which the competent authority may deem necessary to
assess the safety status of the irradiation facility.
10. Please indicate as appropriate:
(a) the irradiation facility is yet to be built
(b) the irradiation facility is already built and equipped
(c) existing irradiation facility is to be modified as per details
enclosed.

11. I hereby certify that:

(1) all the statements made above are correct to the best of my knowledge
and belief.
(2) no operations will be carried out for purposes ether than those
specified under item 7(5) of this form.
(3) all provisions of the Atomic Energy (Control of Irradiation of Food)
rules, 1996, shall be strictly Complied with.
(4) the irradiation facility shall not be transferred/sold/rented by
me/us to another without the prior permission of the competent
authority.
(5) no radiation source for the irradiation unit will be transported
without the prior permission of the competent authority.
(6) full facilities will be recorded by me/us to any authorized
representatives of the competent authority or the licensing authority
to inspect the installations at any time.
(7) radiation surveillance and medical surveillance of all persons
engaged in radiation work as required by the competent authority will
be duly carried out at my/our expense.
(8) all recommendations that may be made from time to time by the
competent authority in respect of radiation safety measures will be
duly implemented. .
(9) duly qualified/ experienced radiological safety officers/ operators/
quality officers will be appointed before the commencement of the
operation of the facility.
(10) the rules regarding decommissioning disposal of decayed sources and
reuse of the site of the decommissioned facility shall be strictly
complied with.

Date: Signature of the Applicant

Seal of the Institution
 FORM IV

[See rule 4 (2))

LICENCE FOR OPERATING AN IRRADIATION FACILITY

Mr./Messers .................................................................
Of...........................................................................
..... having undertaken to comply with all the conditions prescribed in the
Atomic Energy (Control of Irradiation of Food) Rules. 1996 after having paid
the prescribed licence fee and having obtained the certificate of approval
from the competent authority is/are hereby authorised to commission and
operate the irradiation facility described in the application for licence.

This licence is issued on ............................................. and

shall be valid upto................................................. subject
to
conditions printed, overleaf.

Licensing Authority
Seal of office

Condition of licence

1. This licence may be suspended or cancelled if any declaration made or

information given in the application is not carried out.
2. No operations will be carried out for purposes other than those specified
under item 7 (5) of the application for the licence and item 7(5) of the
application for the certificate of approval.
3. All provisions of the Atomic Energy (Control of Irradiation of Foods
Rules, 1996 shall be strictly complied with.

4. The irradiation facility shall not be transferred/sold/rented by me/us

to another without the Prior permission of the competent authority.

5. No radiation source for the irradiation unit will be transported

without the prior permission of the competent authority.

6. Full facilities will be accorded by me/us to any authorized

representatives of The competent authority or the licensing authority to
inspect the installations at any time.

7. Radiation surveillance and medical surveillance of all persons engaged

in radiation work as required by the competent authority will be duly carried
out at my/our expense.

8. All recommendations that may be made from time to time by the

competent authority in respect of radiation safety measures will be duly
implemented.

9. Duly qualified/experienced radiological safety officers/ operators/

quality officers will be appointed before the commencement of the operation
of the facility.
10. Any changes in the personnel listed in this application will be
intimated forthwith to the licensing authority and the competent authority.

11. The rules regarding decommissioning, disposal of decayed sources and

reuse of the site of the decommissioned facility shall be strictly complied
with.

12. A licence shall be valid for a period of three years from the date of
issue of the licence.

FORM V 9. Nature, quality and quantity of

[see rule 11 (1) and (4)] food to be irradiated
Record of food irradiation 10. Purpose of irradiation

1. Identification number of the 11. Type of packaging used during

irradiation facility radiation treatment, if any

2. Name and address of the operator 12. * Specific irradiation conditions

and Quality Control Officer used

3. Serial number of the batch 13. Any other incidents and anomalies
observed during irradiation
4. Date of irradiation treatment.

5. Type of source radionuclide source *Information necessary are:

or X-ray or electron Commissioning, details, machine
source) dose mapping for individual
6. Irradiation Dose products, source position data,
product loading pattern, conveyor
7. Type of Dosimeters used and their operation, number and duration of
calibration process interruption, start and
stopping time of processing and
8. Minimum and Maximum limits irradiation time.
of radiation dose

[No. AE A[17[1]90-ER]
V. ASHOK, Dy. Secy. (ER)